MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC SWIVEL DIRECT FLOW INSERT; SCALER, ULTRASONIC

Model Number UI25SD1000

Device Problem Material Fragmentation (1261)

Patient Problem Needle Stick/Puncture (2462)

Event Date 01/23/2019

Event Type  Injury  

Manufacturer Narrative

Patient weight unknown.Based on the lot number of the device, this device was produced prior to the udi deadline for class 2 devices, therefore udi is not present.The device is not implanted, therefore implant/explant dates are not applicable.No known concomitant medical products and therapy dates.

Event Description

Hygienist was removing an ultrasonic insert from the handle.She was punctured while attempting to remove insert.

• Brand Name: SWIVEL DIRECT FLOW INSERT
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): HU-FRIEDY MFG. CO. LLC; 3232 n rockwell st; chicago IL 60618
• Manufacturer (Section G): HU-FRIEDY MFG. CO. LLC; 3232 n rockwell st; chicago IL 60618
• Manufacturer Contact: maria vrabie ; 3232 n rockwell st; chicago, IL 60618 ; 7738685676
• MDR Report Key: 8352343
• MDR Text Key: 136590591
• Report Number: 1416605-2019-00004
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UI25SD1000
• Device Catalogue Number: UI25SD1000
• Device Lot Number: 0416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR